Pain After Strabismus Surgery
ConditionStrabismus
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age4-12
SponsorAnn & Robert H Lurie Children's Hospital of Chicago
About this trial
At Ann \& Robert H. Lurie Children's Hospital of Chicago (Lurie Children's), the current practice is to prescribe children with oral Tylenol as needed every 4-6 hours post strabismus surgery. Prescribing Tylenol "as needed" leaves more room for error for parents to be under-dosing their children, which can lead to avoidable pain. This study aims to figure out if children ages 4-12 years old will feel significantly less pain and discomfort when given regimented Tylenol every 6 hours for 48 hours after strabismus surgery (eye muscle surgery) compared to controls whose parents are instructed to give Tylenol every 4-6 hours as needed for 48 hours after surgery. To date, there have been no studies comparing patient outcomes between those taking Tylenol regimen and those receiving Tylenol as needed after pediatric surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children between 4-12 years old
Children receiving single muscle, bilateral horizontal strabismus surgery (that is, children who are having only one horizontal eye muscle in each eye operated on) at Lurie Children's hospital in Chicago, IL
ASA classification 1 or 2. Note: ASA is a physical status classification system (scale of 1-6) created by the American Society of Anesthesiologists to describe patients prior to surgery. ASA 1 or 2 means the patient is either healthy or has mild systemic disease prior to surgery.
Disqualifiers
ASA classification 3 or higher (patient has severe systemic disease or worse)
Contraindication to toradol (anesthesia)
Contraindication to acetaminophen
Previous strabismus surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Tylenol
DrugTylenol for children
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Tylenol as neededActive comparator 1 intervention
Group B: Tylenol every 6hrsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Parent reported Pain score using the Parent's Post-operative Pain Measure
Pain score reported by parent validated questionnaire- Scale from 0 to 29, 0 is no pain and 29 is the worst pain.
Time frame
From enrollment to 1 day after surgery2
Child reported pain score using the Faces Pain Scale- Revised
Child reported pain using Faces Pain Scale revised questionnaire. Scale from 0 to 5; 0 is no pain and 5 is the worst pain.
Time frame
2-4 days after surgerySponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: